PD ISO/TS 17665-3:2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Product family (pf)
6 Processing category
7 Sterilization process parameters
8 Additional considerations
Annex A (informative) - Process parameters
Annex B (informative) - Characterization of a
        procedure set - Examples
Annex C (informative) - Designating a processing
        category
Annex D (informative) - Processing categories
        - Examples
Bibliography

Specifies guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of indentifying the aligning it to a processing category for a specific moist head sterilization process.

This part of ISO 17665 provides guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and aligning it to a processing category for a specific moist heat sterilization process.

NOTE While this part of ISO 17665 is applicable to health care facilities, it may be used by a manufacturer of a sterile medical device and/or whenever information on reprocessing is required (see ISO17664).